Merz Announces Clearance of the Cellfina™ System for the Long-Term Reduction of Cellulite

14.7.2016 10:00 | Business Wire

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Merz Pharma Group today announced CE Mark clearance of the Cellfina™
System, signifying its conformity with all EU regulations. Cellfina™ is
intended for long-term reduction of cellulite by precise release of
targeted structural tissue (fibrous septae). Results of treatment with
Cellfina™ are expected to last up to two years. Cellfina™ is currently
available in the U.S. and has the longest duration of results as cleared
by the U.S. Food and Drug Administration (FDA).

“The European clearance of the Cellfina™ System emphasizes Merz’s
commitment to innovation and demonstrates our ongoing leadership in the
global aesthetics space,” stated Philip Burchard, CEO of Merz Pharma
Group. “Recent research we conducted confirmed how widespread of an
issue cellulite is globally, with women having “somewhat to extreme
concern” about the condition. A truly revolutionary aesthetic treatment,
Cellfina™ combines highly advanced, proprietary technology with a
well-established procedure called subcision to treat the underlying
structural problem that causes cellulite. With Cellfina™, Merz continues
to build a portfolio of devices and injectables that provides aesthetic
physicians with effective solutions for common but unmet patient needs.”

In the US IDE pivotal study, 55 patients underwent a single treatment.
The Cellfina™ System improved the appearance of cellulite in 98% of
treated patients at two years, according to independent physician
evaluators. Importantly, 96% of patients reported satisfaction with
their treatment at the two year mark, and noticeable improvement on the
Global Aesthetic Improvement Scale (GAIS) was seen in 100% of treated
patients at two years. The most common side effects reported were
soreness, tenderness and bruising; these side effects resolved quickly
with time.

“Data presented at the 2016 American Society of Aesthetic Plastic
Surgery (ASAPS) Annual Meeting shows that the results from Cellfina™
last at least three years, with a 93% patient satisfaction rate three
years post-treatment,” said Can Gumus, Vice President of Global
Marketing Aesthetics for Merz Pharmaceuticals. “The Cellfina™ System is
currently the only U.S. FDA-cleared and EU CE-Marked minimally-invasive
procedure clinically proven to treat the underlying structural cause of
cellulite. Both patients and physicians can be confident a single 45 to
60 minute treatment with Cellfina™ will deliver significant improvement
in the appearance of cellulite on the buttocks and thighs.”

Following this CE Mark certification, the Cellfina™ System will be made
available to licensed physicians in select markets in Europe through
Merz’s direct European sales force in the second half of 2016.

About Cellfina™

The Cellfina™ System is intended for long-term reduction of cellulite,
up to two years, by precise release of targeted structural tissue
(fibrous septae). Safety and effectiveness in other anatomical areas
have not been established. The most common side effects reported were
soreness, tenderness and bruising. The Cellfina™ System is only
available through a licensed physician. For full product and safety
information, refer to the Instructions for Use.

For more information on Merz Pharma Group, please click on www.merz.com.